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Clinical Trial Support Specialist
2 months ago
Position:
Clinical Trial Support Specialist, Inpatient Unit
About Evolution Research Group:
Evolution Research Group is a prominent U.S.-based, privately owned clinical research organization specializing in clinical development services, particularly in the realm of neuroscience drug development.
With a network of 20 fully owned clinical facilities and 4 affiliated sites, we facilitate both inpatient and outpatient phase I-IV clinical research studies.
Our organization boasts over 400 inpatient beds and a comprehensive database of patients dealing with mental health issues, neurological conditions, sleep disorders, substance dependencies, acute and chronic pain, diabetes, and other health challenges, alongside healthy volunteers participating in trials aimed at advancing medical science.
With access to a vast pool of over 32 million patients and completed studies, Evolution Research Group is committed to enhancing its capabilities and addressing significant unmet medical needs both in the United States and internationally.
Role Overview:
The Clinical Trial Support Specialist plays a crucial role in the execution of clinical trials by ensuring the well-being of trial participants during their stay in the unit.
This position involves assisting in the collection of biological samples, performing venipuncture, conducting electrocardiograms, labeling tubes, processing samples, documenting in participant records, and executing other related tasks as per the physician's directives.
In fulfilling these duties, the Clinical Trial Support Specialist adheres to Good Clinical Practices (GCP), International Conference on Harmonization (ICH) guidelines, Health Insurance Portability and Accountability Act (HIPAA), and the organization's standard operating procedures and policies.
Key Responsibilities:
- Conduct regular safety and status assessments on clinical trial participants as per physician instructions.
- Execute designated research protocol procedures, which may include vital signs monitoring, blood collection and processing, ECGs, and point-of-care laboratory tests.
- Perform basic laboratory tasks as assigned, including preparation of specimen tubes and labels, blood specimen collection, centrifuge operation, and the proper storage and shipping of lab specimens, ensuring accountability and notifying couriers for specimen pickups.
- Ensure the proper disposal of biological specimens.- Maintain a clean and safe working environment for both colleagues and clinical trial participants.
- Engage trial participants in group or individual activities during their stay in the unit.
- Ensure participants have access to linens, toiletries, and other necessary items while residing in the unit.
- Serve meals and provide snacks to clinical trial participants during their stay.
- Study, understand, and comply with Evolution Research Group's standard operating procedures and other relevant policies, practices, and regulations.
- This role may also encompass additional responsibilities as required by the evolving needs of the organization.
This job description serves as a foundational outline and may be subject to further expansion or modification to align with Evolution Research Group's objectives.
Qualifications:
- Education: High school diploma or equivalent.
- Experience: One (1) year of clinical experience preferred.
- Certifications: CPR Certification required; Phlebotomy certification (national) preferred.
- Knowledge: Familiarity with regulatory requirements, Good Clinical Practices (GCP), and International Conference on Harmonization (ICH) guidelines.
- Communication: Ability to interact collaboratively and courteously with providers, colleagues, and others.
- Medical Terminology: Knowledgeable in medical terminology to effectively communicate with healthcare professionals.
- Adaptability: Capable of adjusting behavior to achieve desired outcomes despite changing environmental factors or undefined priorities.
Skills:
- Ability to work independently and collaboratively as part of a team.
- Strong organizational and prioritization skills in a dynamic environment.
- Adherence to safety/universal precautions to protect oneself, participants, and staff.
- Proficient in implementing protocol and regulatory requirements in study conduct.
- Competence in venipuncture, centrifugation, sample storage, and performing electrocardiograms.
- Excellent documentation practices and attention to detail, with a proactive approach to managing changing priorities.
